Legal
”You can’t build a society without law” - Naftali Bennett
Our project is oriented to the safe sending of encrypted information through conventional means (such as regular post) rather than only on the pure storage in bacteria. For that we are providing the Bacillus subtilis spores with several biologic layers.
In this part of Human Practices, we explore the current national and international legislations that the CryptoGErM system must obey in order to ensure its safe and unrestricted shipping.
National Legislations
With the advising of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu; RIVM) from the Ministry of Health, Welfare and Sport from the Netherlands we consulted the current national law requirements and international legislations that regulate the sending of Genetically Modified Organisms (GMOs).
Currently, the shipping of GMOs is strictly regulated in The Netherlands.
Such regulations are stated in the articles 3rd and 4th from the Environmental Regulation of Genetically Modified Organisms (Regeling genetisch gemodificeerde organismen milieubeheer 2013) [1]. These articles state the norms for the deliberate shiping of GMOs within the Netherlands; if the shiping of the Bacillus subtilis spores from the CryptoGErM system is intended within the Netherlands, it must obey this legislation.
According to these articles, “the shipping of Genetically Modified Organism within an Institute, or aboard a ship, must occur in accordance with the following guidelines”
- GMOs must be transferred in a closed, unbreakable, non leaking containers
- Containers of GMOs must be disinfected before shipping
- The dispersion of GMOs to the environment must be avoided by applying the relevant safety measures.
We applied these regulations for the design of the shipping container used for the sending of CryptoGErM spores.
International Legislations
The next step was looking for international laws that regulate the shipping of GMOs around the world, since one of the applications of CryptoGErM is the shipping of Bacillus subtilis spores containing sensitive information across borders.
European legislations
Firstly, we were interested in the European legislations regarding the shipping of GMOs; it was found out that several European Countries, including the Netherlands, follow the regulations and guidelines suggested by the Cartagena Protocol for the transboundary shipment of Genetically Modified Organisms.
But what is it the Cartagena Protocol?
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement on biosafety as a supplement to the Convention on Biological Diversity, whose principal aim is “to ensure the safe handling, transport and use of living modified organisms resulting from modern technology that may have adverse effects on biological diversity, taking also into account risks to human health” [2]
This protocol entered into force during September 2003, and it currently has 170 parties (167 United Nations member states, the State of Palestine and the European Union) [3]. However, other countries such as the United States of America, Canada and Argentina have not signed this agreement.
This protocol states in its Article 18 [4] (Handling, Transport, Packaging and Identification) the suggested documentation associated with the shipping of transboundary shipping of GMOs in order to avoid adverse effects. Such documentation includes:
- Identify them clearly as Genetically Modified Organisms
- Specify any extra requirements for the safe shipping
- Include the contact information to whom the GMOs are consigned
Transatlantic regulations
Secondly, we started to look for the current international legislations and guidelines for the transatlantic shipment of GMOs.
We found out that such shipment is not regulated by just one International Institution, since countries around the world follow different legislations and guidelines between each other; for example, most European Countries, as mentioned above, follow the guidelines suggested by the Cartagena Protocol on Biosafety, however, some countries such as the United States, Argentina, Canada, posses their own legislations for the shipment of GMOs.
Despite the fact that the legislations and guidelines between countries may be different between each other, e.g. Parties and No-Parties of the Cartagena Protocol on Biosafety, the World Health Organization, an international and neutral Institution, launched in 2015 the Guidance on regulations for the Transport of Infectious Substances 2015-2016 [5] to “provide practical guidance to facilitate compliance with applicable international regulations for the transport of infectious substances and patient specimens by all modes of transport, both nationally and internationally”
CryptoGErM must take into account, those three different guidelines and regulations to ensure that the Bacillus subtilis spores containing the encrypted information can be sent freely nationally and internationally.
Consulting national and international regulations, we ensure that CryptoGErM obeys the legal standards for the shipping of GMOs
According to the guidelines from the World Health Organization, the Bacillus subtilis spores used in CrytpoGErM are classified in Class 9 and assigned to UN 3245 since they “do not meet the requirements of infectious substances but are capable of altering animals, plants or microbiological substances in a way which is not normally the result of natural reproduction”
“Bacillus subtilis spores used in CryptoGErM are assigned to UN 3245 for their shipping”
GMOs assigned to UN 3245 must be shipped by following the Packing Instruction P904 [6]. This instruction states the requirements for the container used in the shipping of GMOs:
- An inner package: Primary receptacle and secondary packaging, must be leakproof for liquids or siftproof for solids. In case that the sample is liquid, absorbent material must be placed between the first and secondary packaging
- An outer packaging shall: Strong enough for its capacity, mass and intended use
These requirements are explained graphically in Figure 1 from the “Guide to Shipping Biological Materials” [7] document from the North Carolina University (NCSU). Please refer to this document for graphical consultant of the shipping
However, CryptoGErM found out that the labelling in the transatlantic shipping is not common since the legislations for the transboundary shipping are rather different between countries in America and those in the European Union.
This is particularly true for the Parties and Nonparties of the Cartagena Protocol, whose regulations and legislations are rather different. In order to solve problems that might occur between those parties, it is stated in the Cartagena Protocol that “Parties may enter into bilateral, regional and multilateral agreements to avoid potential conflicts”
We sent the spores of Bacillus subtilis with the encrypted message to the Wageningen UR Team and iGEM TU Eindhoven through the facilities of the University of Groningen to ensure a secure and safe shipping.
References
- [1] Regeling van de Staatssecretaris van Infrastructuur en Milieu. (July 7th, 2016) Retrieved from Regeling Genetisch Gemodificeerde Organismen Milieubeheer 2013. http://wetten.overheid.nl/BWBR0035072/2016-07-01#Hoofdstuk1
- [2] Convention on Biological Diversity. (August 15th, 2016) The Cartagena Protocol on Biosafety. Retrieved from https://bch.cbd.int/protocol/
- [3] Convention on Biological Diversity. (June 6th, 2014) Parties to the Protocol and signature and ratification of the Supplementary Protocol Retrieved from https://bch.cbd.int/protocol/parties/
- [4] Convention on Biological Diversity. (July 16th, 2016) Text of the Cartagena Protocol on Biosafety. Retrieved from https://bch.cbd.int/protocol/text/
- [5] World Health Organization. (January 1st, 2015) Guidance on regulations for the Transport of Infectious Substances 2015-2016. Retrieved from http://apps.who.int/iris/bitstream/10665/149288/1/WHO_HSE_GCR_2015.2_eng.pdf
- [6] UN3373 medical packaging. (June 2016)
- [7] North Carolina State Universuty. (28 September, 2016) Guide to Shipping Biological Materials. Retieved from https://www.ncsu.edu/ehs/dot/Bio_shipping.pdf
